Slides for the FDA SPL Training Webinars

These are the slides from the presentations the FDA is making to clarify what the various SPL submissions need to contain as well as how to submit them. Click on any to view them in PDF form. Please feel free to download them. The content of these slides include the Agency's current thinking on SPL ER/DL; this content may require changes when the final guidance is released.

Module One - Submitting or Requesting an NDC Labeler Code in SPL Format

Module Two - Registration of a Domestics Drug Establishment in SPL Format

Module Three - Registration of a Foreign Establishment in SPL Format

Module Four - Content of Labeling - SPL Format

Module Five - Product Listing Data Elements

Module Six - Submitting SPL R4 v Documents via FDA Gateway !!Not yet available!!